Why Are There Cancer Drug Shortages?

Over the past few years, oncologists have experienced shortages in several older, but curative, chemotherapy drugs, including Doxil and methotrexate. Doxil primarily treats certain severe cases of ovarian cancer and multiple myeloma. Methotrexate treats many forms of cancer, including acute lymphoblastic leukemia, the most common form of childhood leukemia. Other chemotherapy medications, including Vincristine, 5-FU, daunorubicin, cytarabine, and leucovorin, have also been in short supply.

More than half the shortages are due to product quality and manufacturing issues. In addition to compromising patient care, medication shortages spur development of a so-called gray market, a secondary distribution network of drugs, which has a questionable safety and reliability record.

What this means to cancer patientsAccording to Dr. Lawrence Solberg of the Mayo Clinic, "When effective chemotherapy drugs have been unavailable, oncologists have had to turn to alternatives that may be less effective and are often more toxic."

The National Cancer Institute (NCI) reports that shortages also increase the risk of medication errors as hospitals and healthcare facilities cope with dosing frequencies and administering alternative drugs.

When drugs are in short supply, they are typically reserved for those patients for whom therapy is most likely curative. Larger medical centers are generally less likely to experience drug shortages than small outpatient centers.

What's being done?In 2011, Congress introduced the Preserving Access to Lifesaving Medications Act, which requires manufacturers of prescription drugs to notify the FDA of anything that might disrupt production and create a shortage. The Act also mandates a study to identify possible causes of shortages and to establish criteria for evaluating drugs vulnerable to shortages. In November 2011, President Obama signed an executive order to reduce drug shortages.

In mid-February 2012, the FDA took several steps to increase the available supply of drugs. It is allowing importation of Lipodox as a temporary replacement for Doxil. It also approved a new manufacturer of preservative-free methotrexate.

If supplies of your prescribed chemotherapy medication are limited, the pharmacist at your hospital or cancer center will search other locations to find your drugs, or work with your physician to select an alternative medication. You can check the American Society of Health-System Pharmacists (ASHP) and FDA websites, which list reported drug shortages, and complete a shortage report on the ASHP website. Or, contact your congressional representative to tell your story.